title: A novel cautery instrument for on-site fenestration of aortic stent-grafts: a feasibility study of 18 patients.
abstract: OBJECTIVE
  To report the bench-top evaluation and initial clinical use of an instrument for on-site fenestration of aortic stent-grafts.
  
  
  METHODS
  A stainless steel thermal cautery instrument was designed to create circular stent-graft fenestrations from 3 to 10 mm in diameter. Three operators independently bench-tested the instrument on thoracic stent-graft samples to evaluate size, shape, location, and quality of fenestrations created. For clinical use, on-site fenestration was performed 2 days before the endovascular procedure in a sterile room without access to supplemental oxygen. A fenestrator 1 or 2 mm smaller in diameter than the target vessel was used; the edges of the fenestrations were strengthened using flexible radiopaque nitinol wire. The aortic stent-graft was then re-sheathed and sterilized for added safety. Eighteen patients (17 men; mean age 51 years, range 18-80) with a variety of thoracic and juxtarenal pathologies were treated using Zenith TX2, Valiant Captivia, Zenith AAA, and Endurant stent-grafts modified in this manner.
  
  
  RESULTS
  After successful bench testing, the instrument was used to create 34 fenestrations in aortic stent-grafts deployed in the 18 patients. Size and location of fenestrations obtained were as desired. Subsequent catheterization of the fenestration/target vessel and covered stent deployment were successfully achieved in 31 (91%) fenestrations; 2 fenestrations had type III endoleaks and 1 fenestration was unused. There was no perioperative mortality, stroke, embolization, vessel dissection, renal failure, or graft infection. Follow-up to 1 year in the majority of patients has revealed no new fenestration-related problems.
  
  
  CONCLUSIONS
  This simple-to-use instrument makes on-site creation of aortic stent-graft fenestrations easy, accurate, and precise. The instrument is inexpensive, robust, and easily sterilized.
authors.affiliation: 1 Department of Vascular Surgery, Christian Medical College, Vellore, India.
authors.forename: Edwin
authors.initials: E
authors.lastname: Stephen
authors.forename: George
authors.initials: G
authors.lastname: Joseph
authors.forename: Indrani
authors.initials: I
authors.lastname: Sen
authors.forename: Sujith
authors.initials: S
authors.lastname: Chacko
authors.forename: Prabhu
authors.initials: P
authors.lastname: Premkumar
authors.forename: Lijo
authors.initials: L
authors.lastname: Varghese
authors.forename: Dheepak
authors.initials: D
authors.lastname: Selvaraj
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D001012:Aorta, Abdominal / Q000601:surgery*; D001013:Aorta, Thoracic / Q000601:surgery*; D001018:Aortic Diseases / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002425:Cautery / Q000295:instrumentation*; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D011474:Prosthesis Design; D013193:Stainless Steel; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000497:Alloys; D013193:Stainless Steel; C013616:nitinol